BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD

    MDR report key: 19383996 · Received May 22, 2024

    Report

    Report Number
    MW5155312
    Event Type
    Other
    Date Received
    May 22, 2024
    Report Date
    April 1, 2024
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A REGULARLY SCHEDULED DEVICE CHECK & LEAD IMPEDANCE WAS FOUND LV TIP TO CAN. ALTHOUGH THIS ALERT WAS FROM (B)(6) 2023, CHANGED WERE NOT MADE UNTIL DEVICE CK ON (B)(6) 2923. PATIENT STATED SHE HAD, SHORTNESS OF BREATH. LV HISTORICALLY LOW. TRENDS WERE PRINTED. CHANGES TO VSR OFF, AT/AF ALERTS TURNED ON, VT MONITOR ALERT TURNED ON, TOTAL VP LESS THAN 90% TURNED ON, A, RV, AND LV HIGH CAPTURE, MANAGEMENT TURNED ON. PATIENT GIVEN LOW DOSE OF LOSARTAN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300952 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD PERMANENT PACEMAKER ELECTRODE DTB GREATBATCH MEDICAL 511211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown